Trial Outcomes & Findings for Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis (NCT NCT00678470)

Results Overview

Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

22 weeks

Results posted on

2019-04-18

Participant Flow

Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.

Patients were required to have a 2 week washout from topicals and one month washout from any systemic agents.

Participant milestones

Participant milestones
Measure	Intralesional Alefacept Investigational intervention without random assignment Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intralesional Alefacept n=18 Participants Investigational intervention without random assignment Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants

PRIMARY outcome

Timeframe: 22 weeks

Population: Eighteen patients were enrolled in the study and 14 patients completed the entire 22-week protocol. Three patients were lost to follow-up. One patient was discontinued due to persistent elevated liver enzymes determined by the investigators as secondary to heavy alcohol use.

Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.

Outcome measures

Outcome measures
Measure	Single Arm n=14 Participants Investigational intervention without random assignment Intralesional Alefacept: Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
Number of Participants With Either or Both Intralesional Response and Systemic Response Systemic Resp:IL Resp	8 Participants
Number of Participants With Either or Both Intralesional Response and Systemic Response Systemic Resp:IL Nonresp	0 Participants
Number of Participants With Either or Both Intralesional Response and Systemic Response Systemic Nonresp:IL Resp	0 Participants
Number of Participants With Either or Both Intralesional Response and Systemic Response Systemic Nonresp:IL Nonresp	6 Participants

Adverse Events

Intralesional Alefacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Koo MD

University of California at San Francisco

Phone: 4154764701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place